NCT06274411

Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention

Standby Cannulated ECMO Versus Prophylactic ECMO In Patients Undergoing High-Risk Percutaneous Coronary Intervention

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this multicenter, randomized trial is to compare standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk percutaneous coronary intervention (PCI). The main question it aims to answer is : • If standby cannulated ECMO as compared with prophylactic ECMO will improve the outcomes in patients undergoing high-risk PCI

Detailed description

Although coronary artery bypass grafting is generally preferred in symptomatic patients with severe, complex multivessel, or left main disease, some patients present with clinical features that make coronary artery bypass grafting clinically unattractive. Percutaneous coronary intervention (PCI) with hemodynamic support may be feasible for these high-risk patients. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) can be used to provide hemodynamic support during high-risk PCI procedures. However, ECMO might increase the rates of severe complications, such as bleeding and limb ischemia. Additionally, some patients might not need the support of ECMO. In this context, investigators propose a standby cannulated ECMO strategy, in which femoral cannulas are inserted and connected to primed circuit, and ECMO is initiated when needed. Therefore, investigators will conduct a prospective randomized clinical trial to compare outcomes between standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk PCI. Investigators will randomly assign 176 symptomatic patients with complex 3-vessel disease or unprotected left main coronary artery disease or severely depressed left ventricular function to standby cannulated ECMO group (n=88) or prophylactic ECMO (n=88). The primary end point was the 30-day incidence of major adverse events, including all-cause death, myocardial infraction, any repeat revascularization procedure, stroke, PCI failure, limb ischemia, bleeding, surgical revision and renal replacement therapy.

Conditions

• ECMO
• High-risk PCI

Interventions

Type	Name	Description
PROCEDURE	Standby cannulated ECMO	Femoral cannulas are inserted and connected to the primed circuit. Clamps are kept on circuit, and ECMO is on standby during PCI. ECMO is initiated if needed.
PROCEDURE	Prophylactic ECMO	Prophylactic ECMO procedures are performed in the catheterization laboratory before PCI.

Timeline

• Start date: 2025-03-21
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2024-02-23
• Last updated: 2025-09-25

Locations

1 site across 1 country: China